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1.3.2011 EN Official Journal of the European Union C 65/1 IV (Notices) NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES EUROPEAN COMMISSION COMMUNICATION FROM THE COMMISSION TECHNICAL GUIDANCE NOTES FOR IMPLEMENTATION OF REGULATION (EC) No 689/2008 Publication made in accordance with Article 23 of Regulation (EC) No 689/2008 of the European Parliament and of the Council of 17 June 2008 concerning the export and import of dangerous chemicals (2011/C 65/01) TABLE OF CONTENTS Page 1. INTRODUCTION . 3 2. THE ROTTERDAM CONVENTION . 5 3. REGULATION (EC) No 689/2008 . 6 3.1. Article 1: OBJECTIVES . 7 3.2. Article 2: SCOPE . 7 3.3. Article 3: DEFINITIONS . 7 3.4. Article 4: DESIGNATION OF NATIONAL AUTHORITIES . 8 3.5. Article 5: PARTICIPATION OF THE EUROPEAN UNION IN THE CONVENTION . 8 3.6. Article 6: CHEMICALS SUBJECT TO EXPORT NOTIFICATION, CHEMICALS QUALIFYING FOR PIC NOTIFICATION, AND CHEMICALS SUBJECT TO THE PIC PROCEDURE . 8 3.7. Article 7: EXPORT NOTIFICATIONS FORWARDED TO THIRD COUNTRIES . 9 3.8. Article 8: EXPORT NOTIFICATIONS FROM THIRD COUNTRIES . 11 3.9. Article 9: INFORMATION ON EXPORT AND IMPORT OF CHEMICALS . 11 3.10. Article 10: PARTICIPATION IN THE PIC NOTIFICATION PROCEDURE . 12 3.11. Article 11: INFORMATION TO BE SUBMITTED TO THE PIC SECRETARIAT ON CHEMICALS NOT QUALIFYING FOR PIC NOTIFICATION . 12 3.12. Article 12: OBLIGATIONS IN RELATION TO IMPORTS OF CHEMICALS . 12 3.13. Article 13: OBLIGATIONS IN RELATION TO EXPORTS OF CHEMICALS OTHER THAN EXPORT NOTIFICATION . 13 C 65/2 EN Official Journal of the European Union 1.3.2011 Page 3.14. Article 14: EXPORTS OF CERTAIN CHEMICALS AND ARTICLES CONTAINING CHEMICALS 16 3.15. Article 15: INFORMATION ON TRANSIT MOVEMENTS . 16 3.16. Article 16: INFORMATION TO ACCOMPANY EXPORTED CHEMICALS . 16 3.17. Article 17: OBLIGATIONS OF MEMBER STATES AND EXPORTERS FOR CONTROLLING IMPORT AND EXPORT . 19 3.18. Article 18: PENALTIES . 20 3.19. Article 19: INFORMATION EXCHANGE . 20 3.20. Article 20: TECHNICAL ASSISTANCE . 20 3.21. Article 21: MONITORING AND REPORTING . 20 3.22. Article 22: UPDATING ANNEXES . 21 3.23. Article 23: TECHNICAL NOTES FOR GUIDANCE . 21 3.24. Article 24: COMMITTEE . 21 4. THE EUROPEAN DATABASE ON EXPORT AND IMPORT OF DANGEROUS CHEMICALS . 21 5. EXAMPLES . 23 ANNEX 1 — Annex I to Regulation (EC) No 689/2008 of the European Parliament and of the Council 29 ANNEX 2 — Annex II to Regulation (EC) No 689/2008 . 42 ANNEX 3 — Annex V to Regulation (EC) No 689/2008 . 44 ANNEX 4 — Flow charts on the main procedures . 45 ANNEX 5 — Overview of exporters’ main tasks in order to comply with Regulation (EC) No 689/2008 49 ANNEX 6 — List of recommended languages for the labelling of exports to certain countries . 50 ANNEX 7 — List of Designated National Authorities for Regulation (EC) No 689/2008 . 55 ANNEX 8 — List of OECD countries to which waiver for explicit consent could be applied . 61 DISCLAIMER This Guide does not create any new legislative rules. It reflects the Commission’s understanding of Regu­ lation (EC) No 689/2008 and the other legislation referred to. It does not create any new rights or obligations not provided for therein. It should be noted that, in any event, the binding interpretation of Union law is ultimately the role of the Court of Justice of the European Union. ABBREVIATIONS AND DEFINITIONS USED CLP Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 CoP Conference of the Parties DNA Designated National Authority EDEXIM European Database Export Import of Dangerous Chemicals EC European Community 1.3.2011 EN Official Journal of the European Union C 65/3 EEC European Economic Community EU European Union FAO Food and Agriculture Organization of the United Nations GHS Globally Harmonised System of Classification and Labelling Hazard Statement means a phrase assigned to a hazard class and category that describes the nature of the hazards of a hazardous substance or mixture, including, where appropriate, the degree of hazard OECD Organisation for Economic Cooperation and Development PCBs Polychlorinated biphenyls PIC Prior Informed Consent POPs Persistent organic pollutants Precautionary Statement means a phrase that describes recommended measure(s) to minimise or prevent adverse effects resulting from exposure to a hazardous substance or mixture due to its use or disposal R-phrases Phrases describing the risks arising from the dangers involved in using the substance REACH Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals RIN Reference Identification Number S-phrases Phrases describing safety requirements and emergency response procedures relating to the safe use of the substance TARIC Tarif Intégré de la Communauté — i.e., Integrated Tariff of the European Community TFEU Treaty on the Functioning of the European Union UNEP United Nations Environment Programme 1. INTRODUCTION The European Union’s chemical industry is one of the world’s largest chemical producers. Its products include a wide range of substances for a multitude of purposes. Some substances are dangerous to human health and/or the environment and must be used under controlled conditions. Certain chemicals manu­ factured for export and use in other countries are banned or severely restricted within the European Union. It is important to know how to store, transport, use and dispose of dangerous chemicals safely. It is also vital to know what to do in emergency situations, and how to treat medical and environmental problems quickly and effectively. However, in many countries, particularly developing countries, there is a lack of capacity to manage chemicals safely. Workers are often untrained in the proper use and disposal of dangerous chemicals. Governments and companies in these countries may not have appropriate storage and disposal facilities. They may lack knowledge of the hazards of a chemical and how to prevent harm to people and the environment. C 65/4 EN Official Journal of the European Union 1.3.2011 Regulation (EC) No 689/2008 of the European Parliament and of the Council of 17 June 2008 ( 1 ) concerning the export and import of dangerous chemicals is the latest in a series of measures over the years that seek to address this issue. It implements within the EU the Rotterdam Convention on the Prior Informed Consent Procedure (PIC) for certain hazardous chemicals and pesticides in international trade, with a view to protecting human health and the environment from potential harm and contributing to the environmentally sound use of such chemicals. The Regulation also implements a requirement of the Stockholm Convention on persistent organic pollutants, as it bans the export of chemicals identified as persistent organic pollutants in the Convention unless there are specific exemptions foreseen in the Stockholm Convention. It replaces Regulation (EC) No 304/2003 ( 2 ) of the European Parliament and of the Council. ( 3 ) Regulation (EC) No 689/2008 reaffirms the EU’s commitment towards ensuring proper control in the trade and use of dangerous chemicals at the global level, based on the principle that it should help to protect human health and the environment beyond its borders as well as within. The Regulation is based on Article 133 EC (now Article 207 TFEU) and Article 175 EC (now Article 192 TFEU), in order to reflect the impact of provisions on both trade and environmental issues. Regulation (EC) No 689/2008 includes a number of technical amendments to the operative provisions of Regulation (EC) No 689/2008 in light of experience with implementation to date. In particular, and in recognition of the difficulties caused by delays in obtaining responses to requests for explicit consent to import, a procedure is foreseen for allowing exports of certain chemicals to proceed on a temporary basis in the case where, despite all reasonable effort, no response is obtained from the importing country. The Regulation outlines the specific conditions required to allow such waivers and establishes relevant timelines. In addition, under certain conditions a waiver from the obligation to obtain explicit consent is provided for when exporting certain chemicals to countries that are members of the Organisation for Economic Cooperation and Development (OECD). The revised Regulation also enhances and extends the role of the Commission’s database, EDEXIM, by requiring that a system of codes be assigned to export notifications, import decisions, consents and waivers that are maintained in the database. In order to facilitate customs enforcement and reduce administrative burden, exporters are to quote these codes in their export declarations. The Regulation also maintains a number of provisions that go beyond the requirements of the Rotterdam Convention, in order to achieve a higher level of protection to human health and the environment. This Guide opens in section II with an introduction to the Rotterdam Convention, including its basic principles and mechanisms. This section includes a summary of the areas in which the EU Regulation goes beyond the requirements of the Convention. The Guide continues in section III with an article by article review of Regulation (EC) No 689/2008, in which the key requirements of each provision are clearly explained and the relationship between different provisions highlighted. Section IV then outlines the role of the Commission in the day-to-day implementation of the Regulation and in maintaining the EDEXIM database. Finally, section V provides some examples that demonstrate how the requirements of the Regu­ lation play out practically in a range of cases. The Annexes provide useful supplementary information. Annexes 1 through 3 reproduce Annexes I, II, and V of Regulation (EC) No 689/2008. Please note that Annex I to the Regulation is subject to regular updates and the most up-to-date version will be kept available at the Commission’s website at: http://edexim.jrc.ec.
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  • A Novel Mutation in VKORC1 and Its Effect on Enzymatic Activity in Japanese Warfarin-Resistant Rats

    A Novel Mutation in VKORC1 and Its Effect on Enzymatic Activity in Japanese Warfarin-Resistant Rats

    Advance Publication The Journal of Veterinary Medical Science Accepted Date: 8 Sep 2012 J-STAGE Advance Published Date: 26 Sep 2012 Field of paper: toxicology Type of paper: full paper A novel mutation in VKORC1 and its effect on enzymatic activity in Japanese warfarin-resistant rats Kazuyuki D. Tanaka1), Yusuke K. Kawai1), Yoshinori Ikenaka1), Tsunehito Harunari2), Tsutomu Tanikawa2), Shoichi Fujita1), and Mayumi Ishizuka1), 1)Laboratory of Toxicology, Department of Environmental Veterinary Sciences, Graduate School of Veterinary Medicine, Hokkaido University, Kita-18 Nishi-9, Kita-ku, Sapporo 060-0818, Japan 2)Technical Research laboratory, Ikari Corporation, Chiba, 260-0844, Japan Corresponding author: Dr. Mayumi Ishizuka, Laboratory of Toxicology, Department of Environmental Veterinary Sciences, Graduate School of Veterinary Medicine, Hokkaido University, Kita-18 Nishi-9, Kita-ku, Sapporo 060-0818, Japan, Tel:81-11-706-6949 / Fax:81-11-706-5105 e-mail: [email protected] Running head: VKOR OF WARFARIN RESISTANT RATS IN JAPAN 1 ABSTRACT Warfarin is a rodenticide commonly used worldwide. It inhibits coagulation of blood by inhibiting vitamin K 2,3-epoxide reductase (VKOR) activity. An inadequate supply of vitamin K blocks the production of prothrombin and causes hemorrhage. Recently, warfarin-resistant brown rats (Rattus norvegicus) were found around the Aomori area of Japan. There is no significant difference in the metabolic activity of warfarin in sensitive and resistant brown rats. To clarify the mechanism underlying warfarin resistance, we cloned the VKORC1 gene from rats and identified a novel substitution of arginine to proline at position 33 of the VKORC1 amino acid sequence. Then, we determined the differences in kinetics of VKOR activity between warfarin-resistant and sensitive rats.
  • Practice No. 5 Rodenticides

    Practice No. 5 Rodenticides

    Practice No. 5 Rodenticides Rodenticides: • Rodenticides are a group of pesticides which is primarily established for rodent control • There are strict rules how, when and where to use them. In spite of this they are common source of both wild and domestic animals´ poisoning and are also used for malicious intentions to harm • Poisoning is quite easy when baits with rodenticides are placed inconveniently at locations easily accessible for domestic animals esp. dogs and cats • In these animals is also possible to poison themselves by eating a dead rodent which died of rodenticide poisoning – so called secondary poisoning Division of rodenticides: • according to chemical character: - inorganic – zinc phosphide (and other phosphides), formerly arsenic or thallium - organic – natural (strychnine, scilliroside, vitamin D), synthetic (anticoagulants) • according to the route of administration: for eating, for drinking, for dusting, for fumigation • according to the type of action: one dose, cumulative/repetitive intake Zinc phosphide + aluminium phosphide • Phosphides are the only inorganic and single-shot used agents nowadays. Their use is in agriculture, they are not allowed in households. • They are very potent and absolutely non-selective and cause many accidental poisonings • Zinc phosphide is used as feed bait and aluminium phosphide is fumigated in closed spaces (stocks, stores). • Feed baits are made of grains impregnated by zinc phosphide or they are granules with active substance. Usually are not colourful! • Often cause poisonings